CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
Check against the official notice below — it lists the full affected range.
Cook Inc. is recalling six CrossCath Support Catheters (model RPN CXC3.4-2.2-18-90-P-NS-0, lot number 9945303) due to a manufacturing error affecting the radiopaque marker bands. The marker bands may be too loose on certain CXC3.0 models compatible with 0.014 wire guides and too tight on certain CXC3.4 models compatible with 0.018 wire guides. These catheters are used for diagnostic and interventional vascular procedures.
The affected catheters were distributed to medical facilities in Alabama, California, Connecticut, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, and Brazil. The recall source does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides).
Reason for recall: A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 CrossCath Support Catheters (compatible with 0.018 wire guides). Distribution: Distribution to US states of AL, CA, CT, FL, GA, IL, MA, MD, MI, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, and VA, and Brazil. Quantity: 6 Lot/code info: Lot Number 9945303 UDI: (01)00827002515758(17)221308(10)9945303
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.